Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2).

Abstract

BACKGROUND:

Certolizumab pegol, the only Fc-free, PEGylated anti-tumor necrosis factor biologic, demonstrated clinically meaningful improvements suggestive of a positive risk-benefit balance in phase 2 studies in adults with moderate-to-severe chronic plaque psoriasis.

OBJECTIVE:

Assess certolizumab efficacy and safety versus placebo in phase 3 studies.

METHODS:

Patients with moderate-to-severe chronic plaque psoriasis were randomized 2:2:1 to certolizumab 400 mg, certolizumab 200 mg, or placebo every 2 weeks. At week 16, certolizumab-treated patients achieving a 50% reduction in Psoriasis Area and Severity Index continued treatment through week 48. Coprimary endpoints were week 16 responder rates, defined as a 75% reduction in Psoriasis Area and Severity Index and Physician's Global Assessment 0/1 (clear/almost clear) and ≥2-point improvement. Safety was assessed by treatment-emergent adverse events.

RESULTS:

Week-16 endpoints were significantly greater for both doses of certolizumab versus placebo, and the responses were maintained through week 48. For most measures, improvement was numerically greater for certolizumab 400 mg. No unexpected safety signals were identified.

LIMITATION:

There was no active comparator.

CONCLUSION:

Treatment with either certolizumab 400 mg or 200 mg every 2 weeks was associated with significant and clinically meaningful improvements in moderate-to-severe psoriasis. The 400-mg dose could provide additional clinical benefit. The safety profile was consistent with the therapeutic class.

• Authors: Alice B Gottlieb, Andrew Blauvelt, Diamant Thaçi, Craig L Leonardi, Yves Poulin, Janice Drew, Luke Peterson, Catherine Arendt, Daniel Burge, Kristian Reich
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 79 Issue 2 Pg. 302-314.e6 (Aug 2018) ISSN: 1097-6787 [Electronic] United States
• PMID: 29660421 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2018 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Biological Products
• Dermatologic Agents
• Tumor Necrosis Factor-alpha
• Certolizumab Pegol

Topics

• Adult
• Biological Products (adverse effects, therapeutic use)
• Certolizumab Pegol (adverse effects, therapeutic use)
• Chronic Disease
• Dermatologic Agents (adverse effects, therapeutic use)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Male
• Middle Aged
• Psoriasis (drug therapy)
• Quality of Life
• Severity of Illness Index
• Treatment Outcome
• Tumor Necrosis Factor-alpha (antagonists & inhibitors)